Study With GW274150 In Patients With Mild Asthma

Asthma Clinical Trial

Official title:

Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273013
• Other study ID #: INO102141
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2006
• Last updated: October 17, 2017
• Start date: November 15, 2004
• Est. completion date: October 28, 2005

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 28, 2005
• Est. primary completion date: October 28, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion criteria:

• Mild asthma: taking reliever medication (e.g. salbutamol) only.

• Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.

Exclusion criteria:

• Recent steroid treatment.

• Significant illnesses or diseases other than asthma.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW274150
GW274150 will be available as 30 mg white oval tablets.
• Singulair
Singulair will be available as over encapsulated 10 mg orange tablets.
• Placebo
Matching placebo for Singulair and GW274150 will be available.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on the late asthmatic reaction following an inhaled allergen challenge		Up to Day 115
Secondary	Measures of safety. Measures of lung function		Up to Day 115

External Links

•   Results for study 102141 can be found on the GSK Clinical Study Register.